temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion & pressure • cough due to minor throat & bronchial irritation • cough to help you sleep • minor aches & pains • headache • fever • sore throat • runny nose & sneezing • reduces swelling of nasal passages • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage
•take only as directed • do not exceed 8 caplets per 24 hrs adults & children 12 yrs & over 2 caplets with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCL 5 mg
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
temporarily relieves common cold/flu symptoms:
• nasal congestion • sinus congestion & pressure • cough due to minor throat & bronchial irritation
• cough to help you sleep • minor aches & pains • headache
• fever • sore throat • runny nose & sneezing
• reduces swelling of nasal passages
• temporarily restores freer breathing through the nose
• promotes nasal and/or sinus drainage
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than 8 caplets in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product
Allergy Alert: acetaminophen may cause severe skin reactions. Symptoms may include: • Skin reddening • Blisters • Rash
If a skin reaction occurs, stop ues and seek medical help right away
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
• liver disease • heart disease • high blood pressure • thyroid disease
• diabetes • glaucoma • cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
• trouble urinating due to enlarged prostate gland
• taking sedatives or tranquilizers • taking the blood thinning drug warfarin
• do not use more than directed
• excitability may occur, especially in children • marked drowsiness may occur
• avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery
• alcohol, sedatives, and tranquilizers may increase drowsiness
• you get nervous, dizzy or sleepless • pain, nasal congestion, or cough gets worse or lasts more than 7 days
• fever gets wore or lasts more than 3 days • redness or swelling is present • new symptoms occur
• cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
•take only as directed • do not exceed 8 caplets per 24 hrs
adults & children 12 yrs & over 2 caplets with water every 4 hrs
children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use
• do not exceed 25ºC
crospovidone, D&C Yellow No.10 Aluminum Lake, FD&C Blue No.1 Aluminum Lake, FD&C Blue No.2 Aluminum Lake,FD&C Yellow No.6 Aluminum Lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide
1-800-362-1683
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1546881 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 1 |
| 1546881 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 1 |
| 1546881 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet | SY | 1 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DOXYLAMINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 73097-009-02 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1356-a910-e053-dadaa90a0b85 | NyQuil Severe Cold & Flu |
| 73097-009-20 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1356-a910-e053-dadaa90a0b85 | NyQuil Severe Cold & Flu |
| 73097-009-25 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1356-a910-e053-dadaa90a0b85 | NyQuil Severe Cold & Flu |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 73097-009-02 | NyQuil Severe Cold and Flu | 1 in 1 CARTON | TABLET, COATED | 1 | 1 | |
| 73097-009-02 | NyQuil Severe Cold and Flu | 2 in 1 POUCH | TABLET, COATED | 2 | 1 | |
| 73097-009-20 | NyQuil Severe Cold and Flu | 40 in 1 CARTON | TABLET, COATED | 40 | 1 | |
| 73097-009-20 | NyQuil Severe Cold and Flu | 2 in 1 POUCH | TABLET, COATED | 2 | 1 | |
| 73097-009-25 | NyQuil Severe Cold and Flu | 2 in 1 POUCH | TABLET, COATED | 2 | 1 | |
| 73097-009-25 | NyQuil Severe Cold and Flu | 50 in 1 CARTON | TABLET, COATED | 50 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 73097-009 | NYQUIL SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [SAVINGS DISTRIBUTORS LLC] | 1 | Legacy NDC, 6 package rows | 20190719_8de6c330-fae4-438c-e053-2a95a90ab640.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 73097-009 | 73097-009-25, 73097-009-02, 73097-009-20 |
| 37000-813 |
Every source-derived ingredient row is available through these pages.
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 8de6a5b5-0a1f-29df-e053-2a95a90af75e | 8de6c330-fae4-438c-e053-2a95a90ab640 | 2019-07-17 | Warnings | 8de6a5b5-0a1f-29df-e053-2a95a90af75e 8de6c330-fae4-438c-e053-2a95a90ab640 |
Adverse event summaries are temporarily unavailable. Other product information remains available.